Developing a diagnostic tool for myofascial pain in foot conditions
QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding Biomarkers
NA · University of Iowa · NCT06803056
This study is testing a new way to identify and measure myofascial pain in people with plantar fasciitis and Achilles tendinopathy to help improve their treatment options.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Iowa (other) |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT06803056 on ClinicalTrials.gov |
What this trial studies
This study aims to create a diagnostic biosignature using advanced imaging techniques to accurately identify and measure abnormal myofascial tissue in individuals with plantar fasciitis and Achilles tendinopathy. By employing a cross-sectional study design, participants will be divided into three groups: those with plantar fasciitis, those with Achilles tendinopathy, and pain-free controls. The goal is to differentiate between myofascial pain and other types of foot pain, ultimately improving personalized treatment options. The study will utilize clinical exams, ultrasound imaging, and magnetic resonance imaging to gather data.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older with a clinical diagnosis of plantar fasciitis or Achilles tendinopathy lasting at least 3 months.
Not a fit: Patients with acute foot pain, those under 18, or individuals with contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and personalized treatment plans for patients suffering from myofascial pain.
How similar studies have performed: While similar imaging techniques have been explored, this specific approach to developing a diagnostic biosignature for myofascial pain is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria for plantar fasciitis group: * Clinical diagnosis of plantar fasciitis * Duration of plantar fasciitis pain greater than or equal to 3 months * Severity of plantar fasciitis pain greater than or equal to 3/10 Inclusion criteria for Achilles tendinopathy group: * Clinical diagnosis of insertional Achilles tendinopathy: * Duration of Achilles tendinopathy pain greater than or equal to 3 months * Severity of Achilles tendon pain greater than or equal to 3/10 Control group: • Similar age, sex, and BMI as plantar fasciitis and Achilles tendinopathy groups Exclusion criteria: * Younger than 18 years of age * History of an invasive procedures to the foot and ankle on the side of interest * History of lower extremity injections, dry needling, or EPAT/ESWT within past 3 months on the side of interest * Contraindications for MRI (e.g. non-MR compatible implanted devices, claustrophobia, inability to remain still comfortably for 1 hour in a supine position, body size too large for MR scanner) * Clinically unstable medical or psychiatric issues * Pregnant or possibly pregnant * Co-morbidities associated with changes in musculoskeletal imaging, including: Diagnosed systemic conditions affecting the foot and ankle (e.g., rheumatoid arthritis, spondyloarthropathy, gout) endocrine disorder with complications (e.g., uncontrolled Type I or II diabetes, diabetic peripheral neuropathy) Neuromuscular diseases (e.g., Charcot-Marie-Tooth (CMT) disease) Connective tissue disorder (e.g. Marfan's syndrome, Ehlers-Danlos) Osteoarthritis of the foot or ankle History of foot or ankle fracture Infection of the foot or ankle (e.g., infectious fasciitis, calcaneal osteomyelitis) within the past year Familial hypercholesterolemia Neoplasms involving the foot, Plantar fibromatosis * Control group only: Persistent or recurrent leg pain in the past 6 months * Plantar fasciitis and Achilles tendinopathy groups only: Other source of heel or foot pain (e.g., tarsal tunnel syndrome, peripheral neuropathy, lumbar radiculopathy, calcaneal stress fracture, Morton's neuroma, fibromyalgia) or co-occurring plantar fasciitis and Achilles tendinopathy (for the Achilles tendinopathy group).
Where this trial is running
Iowa City, Iowa
- University of Iowa Health Care — Iowa City, Iowa, United States (RECRUITING)
Study contacts
- Principal investigator: Kathleen Sluka, PT, PhD — University of Iowa
- Study coordinator: Jing Danielson, DDS
- Email: chimenti-lab@uiowa.edu
- Phone: 319-356-1722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Plantar Fasciopathy, Achilles Tendinopathy, Controls, plantar fasciitis, achilles tendinitis, biomarker, myofascial, magnetic resonance imaging